Dilip Nair PMP®

Experience

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  Lambda Therapeutic Research

  Jan 2003 - Nov 2009

  Worked closely with sponsor representative, in-house quality assurance team, project team members, investigators, finance, management and vendor personal.Liable to manage studies of different phases (pre-phase, phase and post-phase).Assisted project manager / CTL for developing and using a Clinical Trial Management Plan (CTMP) as a management tool to record and measure progress, such as roles and responsibilities, communication plan, subject recruitment strategy, mile stone achievement, monitoring discrepancies etc.Effectively communicated with team members regarding the scope of work, timeline and project goals, technical information, and input from sponsor throughout the project.Ensured study specific management tools and central file maintenance plan as per requirement(s).Data clarification form resolution & tracking from various study sites. Made sure timely preparation, compilation, QC checks, review, audit and dispatch of clinical study reports Show less - Ensured data quality, consistency and timelines for project management plan.- Preparation of protocol, ICFs and CRFs in consultation with clinical operations and data management.- EC submissions.- Vendor coordination - Addressed response to quality assurance audit findings.- Preparation of various logs for clinical trials (ICF, SAE, AE, screening, subject identification, site signature, site delegate, temperature, monitoring discrepancy logs, etc.). - Reconciliation statement for clinical supplies. Show less Preparation of SMFs, CIF and CSF.Participated in study related activities and quality control checks.Protocol compilation and submission to IEC for approvalLiable for protocol compilation and submission to IEC for approval.Administrating Office – hiring of contractual staff, coordinating their payments, stationery, food & stay arrangement etc.Tracking of investigator fees, EC fees, etc.Updating the study status.Archiving of project related documents, logbooks, calibration records etc.Coordinating with CRA for subject follow-up.Harmonizing with vendor for shipment and collection of the study materials Show less

  • Sr. Clinical Research Associate (Project Management)

    Jan 2007 - Nov 2009

  • Clinical Research Associate - BA/BE & Clinical Trials

    Jan 2005 - Dec 2006

  • Clinical Trial Assistant (Study Coordinator) - BA/BE & Clinical Trials

    Jan 2003 - Dec 2004
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  Abbott

  Dec 2009 - Sept 2014

  Manager- CRO

  •Recipient of “Value Award” for demonstrating the value of “Pioneering” & “Excellence Award” on February 2014.•Project Lead for the first Abbott Nutrition clinical study in India,the results of which has been published in the national and international journals. •SME for CRO and other vendor qualification and management.•Project management of multiple international & domestic clinical studies making sure that project timelines are met while adhering to ICH - GCP & SOPs.•Woking closely with affiliate finance department, commercial team for study budget projection & allocation. •Effective communication of clinical project related information to clinical teams & upper management through regularly scheduled meetings, meeting minutes & presentations as needed.•Managed on-site qualification,Initiation & monitoring,including risk-based monitoring•Responsible for leading the coordination of activities over cross-functional areas for the completion of clinical study protocols, amendments, case report forms, source documents, investigator meetings, monitoring plans,data management plan, data review, database release, topline results & clinical study reports.•Coordinate with lead scientists in designing & writing scientific documents such as protocols, amendments, clinical study reports & manuscripts.•Review & approval of routine monitoring visit trip reports.•Training of site, affiliate & CRO personnel•CRO qualification & selection.•EC Submissions & CTRI registration.•SAE Reconciliation with medical safety and surveillance team.•Closely working withCDMteam from CRF development to database lock.•Planning, directing & managing of designated projects by using CTMS•Responsible for Project Service Management including IMP handling,agreements & CDA execution, documents management,study payments & vendor payment etc.•Actively participated in the process improvement committees (trip report, SOP revision & centralized monitoring committee etc.) Show less

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  IMS Health

  Oct 2014 - Mar 2015

  Consultant - Clinical Trials Optimization (CTO)

  - Clinical Trial analysis & bench-marking.- To generate reports, analyze data, identify and implement area of improvement in existing clinical trial optimization offerings (Site Optimizer, Study Optimizer & Grant-plan).- Collaborate with Global process optimization team and IT team on enhancements and development of new clinical trial optimization offerings

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  ClinChoice - (FTE Role for J&J Consumer)

  Apr 2015 - Aug 2020

  Project Manager

  FTE role for J&J Consumer- Monitor the project closely throughout the engagement with the customer and keeps a close contact with customer - Accomplishes project objectives by planning and evaluating project activities - Facilitate the definition of project scope, goals and deliverable - Define project tasks and resource requirements - Develop full scale Project Management plans, assemble and coordinate project staff - Manage project budget, project resource allocation, plan and schedule project timelines - Track project deliverable/ SLAs using appropriate tracking tools and provide direction and support to project team - Constantly monitor and report on progress of the project to all stakeholders - Reporting to client and internal stakeholders Resource Management - Working closely with Global Portfolio Manager- Maintaining resource records and keeps a current project tracking log detailing issues, risks, open items and change requests. - Attending meetings & project workshops. - Providing team communication resource updates/slide presentations to management - Assemble and maintain projections of resource demands and detailed resource pool information. Show less

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  Sanofi

  Sept 2020 - now

  • Lead programs and projects across functions • Maintain roadmaps, project plans, reports and dashboards (e.g., incl. Requirements for budgeting) • Hold regular alignment meetings with relevant stakeholders• Ensure adherence to timelines and quality as per requirements Key Areas* Stakeholder management* Project management* Budget management* Process optimization

  • Global RWE Operations Lead (Operations/ Governance)

    Jul 2023 - now

  • Real World Evidence - Planning & Operation Management

    Sept 2020 - Jun 2023